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Myocet Plus Endoxan for Older Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT01120171
Recruitment Status : Terminated (Due to poor accrual)
First Posted : May 10, 2010
Last Update Posted : October 7, 2015
Information provided by (Responsible Party):
Hellenic Oncology Research Group

May 5, 2010
May 10, 2010
October 7, 2015
September 2009
May 2015   (Final data collection date for primary outcome measure)
Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI every 3 months ]
Same as current
Complete list of historical versions of study NCT01120171 on ClinicalTrials.gov Archive Site
  • Toxicity profile [ Time Frame: Toxicity assessment every month ]
  • Time to Tumor Progression [ Time Frame: 1-year ]
  • Overall Survival [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
Myocet Plus Endoxan for Older Patients With Breast Cancer
Liposome-encapsulated Doxorubicin (Myocet) Plus Cyclophosphamide as First or Second Line Therapy for Older Patients With Metastatic Breast Cancer
This study will evaluate the efficacy, safety and effect on quality of life of liposomal-encapsulated doxorubicin in combination with cyclophosphamide as first or second line treatment of older patients (≥ 70 years old) with metastatic breast cancer. The efficacy of the combination will be correlated with the functional status of patients according to the comprehensive geriatric assessment
Elderly individuals make up a large part of the breast cancer population. When treated with chemotherapy for metastatic disease they derive similar benefits to their younger counterparts. Anthracyclines are associated with a cumulative dose-dependent cardiomyopathy with increased rate in patients over the age of 70. Liposomal-encapsulated doxorubicin improves the therapeutic index of doxorubicin by reducing significantly the cardiotoxicity and grade 4 neutropenia and provides comparable antitumor efficacy, when used in combination with cyclophosphamide as first-line therapy for metastatic breast cancer
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Cyclophosphamide

    Cyclophosphamide (IV) 600 mg/m2 on day 1. Treatment repeats every 21 days. Primary prophylaxis with pegfilgrastim (6 mg) administered 24 hours after chemotherapy.

    Therapy will continue until maximum response,or unacceptable toxicity.

    Other Name: Endoxan
  • Drug: Liposomal-encapsulated doxorubicin

    Liposomal-encapsulated doxorubicin (IV) 50 mg/m2 on day 1. Treatment repeats every 21 days.

    Primary prophylaxis with pegfilgrastim (6 mg) administered 24 hours after chemotherapy.

    Therapy will continue until maximum response or unacceptable toxicity.

    Other Name: Myocet
Experimental: 1
Cyclofosfamide/Liposomal-encapsulated doxorubicin
  • Drug: Cyclophosphamide
  • Drug: Liposomal-encapsulated doxorubicin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
May 2015
May 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic breast adenocarcinoma
  • No more than one prior therapy regimen (other than hormonal therapy) for metastatic breast cancer is acceptable.
  • Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
  • Performance status (WHO) 0-2
  • Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases)
  • Adequate renal function (serum creatinine <1.5 times the upper normal limit)
  • Adequate cardiac function (LVEF within normal limits)
  • Adequate bone marrow function (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
  • No radiation of measurable disease (except brain metastases)
  • No progressive brain metastases according to clinical or radiological criteria
  • No brain metastases without prior radiation therapy
  • Written informed consent

Exclusion Criteria:

  • Active infection
  • History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
  • Prior treatment with an anthracycline-containing regimen (as adjuvant therapy) during the previous 12 months period
  • Other invasive malignancy except non-melanoma skin cancer
  • Psychiatric illness or social situation that would preclude study compliance
  • Pregnant or lactating women
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Hellenic Oncology Research Group
Hellenic Oncology Research Group
Not Provided
Principal Investigator: Dimitris Mavrudis, MD University Hospital of Crete
Hellenic Oncology Research Group
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP